FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERDRY TEXTILE WITH SILVER
K Number: K061615
·
Decision Dec 22, 2006
Classifications
1
FEI Numbers
391
Registration Numbers
392
Same Product Code
18
Applicant Total
2
Review Days
196
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Basic Information
- Device Name
- INTERDRY TEXTILE WITH SILVER
- K Number
- K061615
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5300
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Milliken Chemical
- Date Received
- June 9, 2006
- Decision Date
- December 22, 2006
- Product Code
- FRL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | FDA class 1 | General Hospital |
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Other Clearances by Milliken Chemical
| K Number | Device Name | ||
|---|---|---|---|
| K051445 | MILLIKEN SILVER WOUND DRESSINGS | Aug 22, 2005 | Substantially Equivalent |